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Jena, Germany, March 7, 2025 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced the presentation of multiple posters describing the utility of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), including clinical efficacy data, safety assessments, and pharmacokinetic (PK) and pharmacodynamic (PD) analyses. These data are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting being held March 7 - 11, in Orlando, FL.
Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “At AAD 2025, we presented multiple data sets we believe collectively paint a broad and positive picture of vilobelimab’s potential in addressing inflammatory conditions such as hidradenitis suppurativa and pyoderma gangrenosum. Multiple safety analyses showed vilobelimab to be well-tolerated in HS, and in the rare and devastating disease of PG, in which patients are often very ill and have co-morbidities. We also presented data showing vilobelimab can reduce and resolve draining tunnels, including a 3.1x relative improvement in dT100 response. Multiple analyses also showed vilobelimab can promote significant and sustained reductions in C5a, which is a key mediator of the inflammatory cascade. We believe that the C5a/C5aR pathway remains critical in these neutrophilic-driven diseases.”
Vilobelimab in PG at AAD 2025
In PG, InflaRx presented two analyses from the previously completed Phase 2a dose-finding study. In an oral poster session (#63560), the Company presented safety data, showing that adverse events (AEs) were mostly mild to moderate. The data also showed vilobelimab to be well tolerated across all doses, with no specific safety concerns associated with vilobelimab and no dose relationship observed. In addition, no clinically relevant findings for vital signs, ECGs, hematology, clinical chemistries or urinalysis were seen.
In an ePoster (#63550), InflaRx presented PK/PD data in PG measuring relative changes in C5a concentrations from baseline in three vilobelimab dose groups. C5a decreased from baseline throughout the study, with an approximate 90% reduction observed by Day 15 in all dose groups and sustained in Group 2 (1600 mg bi-weekly) and Group 3 (2400 mg bi-weekly) out to Day 99. The PK/PD analysis also suggested that doses greater than 1600mg given bi-weekly of vilobelimab are needed in ulcerative PG patients to suppress C5a. The ongoing Phase 3 trial is utilizing vilobelimab dosed at 2400 mg bi-weekly.
Vilobelimab in HS at AAD 2025
InflaRx also presented multiple posters related to the Phase 2b SHINE trial studying vilobelimab in HS. A post-hoc analysis (#63490) assessed the impact of vilobelimab on reducing dT, which are a tremendous burden on patients and sometimes require invasive surgery. Vilobelimab showed a significantly greater reduction in mean dT count versus placebo of -63.2% versus -18.0%. Vilobelimab demonstrated a significantly higher rate of complete resolution of dT (dT100) versus placebo of 40.9% versus 13.0%, for a 3.1x relative responder improvement in favor of vilobelimab.
Additional data presented from SHINE included a safety analysis (#63527), which showed that vilobelimab was well tolerated with a similar frequency, severity and pattern of AEs observed at all doses compared to placebo. In addition, the extension trial period had similar rates and severity of AEs to the main trial period.
Featured in an ePoster (#63454), a PK/PD analysis showed that the administration of 800mg vilobelimab resulted in trough levels which significantly reduced C5a concentrations from Day 1. While C5a concentrations gradually increased after the treatment period, they remained lower than baseline during the follow-up to Day 134, indicating a residual treatment effect.
#63560
Oral poster presentation: Vilobelimab Safety in Pyoderma Gangrenosum Patients: A Phase 2a Explorative Dose-Finding Study
Authors: Afsaneh Alavi, Benjamin H. Kaffenberger, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
Date/time: Mar 8, 2025, 10:15 AM - 10:20 AM
#63550
ePoster: Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab and Complement C3 and C5a in a Randomized, Controlled Multidose Phase 2a Study in Pyoderma Gangrenosum
Authors: Afsaneh Alavi, Hoda Tawfik, Camilla Chong, Joseph F. Grippo, Bruce P. Burnett
#63490
ePoster: Reduction in Draining Tunnels in Hidradenitis Suppurativa Patients Treated with Vilobelimab in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b Study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek C Szepietowski, Falk Bechara, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
#63505
ePoster: Vilobelimab Post-hoc Efficacy in Hidradenitis Suppurativa using the Modified-HiSCR with Data from the Phase 2b SHINE Study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Camilla Chong, Hoda Tawfik, Bruce P. Burnett
#63527
ePoster: Vilobelimab Safety in Hidradenitis Suppurativa Patients in a Randomized, Placebo-Controlled, Double-Blind Multicenter Phase 2b study
Authors: Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek C Szepietowski, Falk Bechara, Hoda Tawfik, Camilla Chong, Bruce P. Burnett
#63454
ePoster: Pharmacokinetic/Pharmacodynamic Analysis of Vilobelimab Demonstrates a Significant Reduction of C5a Levels in Hidradenitis Suppurativa Patients
Authors: Evangelos J. Giamarellos-Bourboulis, Theodora Kanni, Hoda Tawfik, Camilla Chong, Joseph F. Grippo, Bruce P. Burnett
About GOHIBIC (vilobelimab)
In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website http://www.gohibic.com.
In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.
About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.com.
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
InflaRx N.V.
Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
MC Services AG
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +1-339-832-0752
FORWARD-LOOKING STATEMENTS
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